Background/Objectives: Psoriasis is a chronic immune-mediated skin disease associated with several metabolic comorbidities. Metabolic dysfunction-associated steatotic liver disease (MASLD) is also linked to psoriasis, but evidence regarding the severity of this association remains inconclusive. This meta-analysis aimed to investigate the relationship between MASLD and varying severities of psoriasis. Methods: We conducted an extensive search of four databases, MEDLINE, EMBASE, OSF, and ClinicalTrials.gov to identify relevant published articles assessing the risk of prevalent MASLD in patients with moderate-to-severe psoriasis up to April 2024. Effect estimates from each included study were combined together to calculate a pooled effect estimate for the meta-analysis using the generic inverse variance method of DerSimonian and Laird. Results: This meta-analysis included eight studies with a total of 109,806 participants. A 4.01-fold increased risk of prevalent MASLD was observed in patients with moderate-to-severe psoriasis compared to those without psoriasis (95% CI: 2.17, 7.77; I2 = 67%, p < 0.0001). The evidence supporting this outcome had low certainty. Conclusions: An incremental trend of MASLD was observed in patients with moderate-to-severe psoriasis. Routine screening for MASLD should be emphasized in this population.
10 October 2024 in Alimentary Pharmacology & Therapeutics
Background: Given the introduction of new advanced therapies for inflammatory bowel diseases (IBDs), expanded risk mitigation strategies are essential.Aims: To create a comprehensive set of statements on assessment procedures and vaccinations before starting monoclonal antibodies, Janus kinase (JAK) inhibitors or sphingosine‐1‐phosphate (S1P) modulators for IBD.Methods: We examined literature, guidelines and drug product information regarding vaccination and assessment recommendations for initiating advanced IBD therapies. Using a modified Delphi approach, delegates voted anonymously on the acceptability of these statements prior to and following consensus discussion.Results: We developed eight statements on the domains of infectious diseases screening, vaccinations and assessments prior to commencing JAK inhibitors and S1P modulators. Six statements received agreement. Pre‐advanced therapy screening for infectious diseases was established, and the vaccination protocol was revised. Malignancy, cardiovascular and thromboembolic risk assessments are necessary before initiating JAK inhibitors. Those starting S1P modulators need cardiac and ophthalmic assessments.Conclusions: These consensus statements combine vaccination and assessments on the currently available advanced therapies for IBD as a single comprehensive document that may reduce IBD complications associated with use of advanced therapies. Knowledge gaps identified during the consensus process will provide further research opportunities.
15 October 2024 in Alimentary Pharmacology & Therapeutics
Summary: Background: There are a plethora of therapeutic options for the management of inflammatory bowel disease (IBD). Despite this, clinical outcomes with standard dosing often fall short of established targets. While efforts centre on developing novel therapies, there is an ongoing need to optimise the use of existing agents.Aims: To focus on strategies to optimise response to biologic (monoclonal antibody) therapies in IBD, including use of therapeutic drug monitoring (TDM).Methods: An extensive review of the published literature.Results: TDM is a strategy aimed at enhancing the effectiveness of drugs with variable exposure‐response relationships by measuring serum concentrations of biologic therapies and detecting neutralising antibodies. Reactive TDM is performed when therapeutic goals have not been achieved. Tumour necrosis factor alpha (TNF) inhibitors are the treatment class most frequently associated with immunogenicity and loss of response. Immunogenicity can be reduced through avoidance of low serum drug concentrations by dose optimisation or use of concomitant immunomodulator therapy. Subtherapeutic dosing in the absence of antidrug antibodies is best managed by dose escalation or dose interval reduction. Persistent neutralising drug antibodies necessitate switching to an alternative therapy. Proactively ensuring adequate serum trough levels might help sustain treatment durability and prevent loss of response. Newer non‐TNF inhibitors demonstrate less robust exposure‐response relationships, and TDM may not prove as beneficial.Conclusions: In the treat‐to‐target paradigm of IBD treatment, optimising treatment effect with dose optimisation, which may involve strategies including TDM, increases the likelihood of achieving clinical remission and may accomplish deeper levels of remission beyond symptom control.
INPLASY202510068 The Risk of Metabolic Dysfunction-Associated Steatotic Liver Disease in Moderate-to-Severe Psoriasis: A systematic review and meta-analysis Psoriasis; meta-analysis; liver disease;…
3 January 2025 in Therapeutic Advances in Gastroenterology
Background: The association between inflammatory bowel disease (IBD) activity and poor sleep quality is reported. However, most research subjectively investigated this issue and lacked long-term follow-up. Objectives: Our study aimed to investigate the prevalence of sleep disturbance in IBD patients across disease activity and evaluate the long-term correlation between disease activity, sleep quality, and quality of life. Design: This prospective observational study assessed sleep quality in patients with IBD. Methods: Patients with IBD were categorized into groups based on clinical activity scores. The sleep questionnaire (Pittsburgh Sleep Quality Index (PSQI)) and IBD questionnaire (IBDQ) were evaluated monthly for 12 months. Seven-day sleep data from wrist actigraphy (Actiwatch®) were collected at initiation and completion. Longitudinal correlation was analyzed. Results: A total of 98 participants were enrolled, consisting of 68 remission, 21 mild, and 9 moderate-to-severe disease activities. At baseline, 60% of participants demonstrated poor sleep quality, defined by a PSQI of >5. The group with greater disease severity reported numerically poorer sleep quality; however, this difference was not statistically significant. On actigraphy, there was no statistically significant difference in sleep latency, wake after sleep onset, or sleep efficiency between the groups. During follow-up, 90 patients responded to questionnaires. The mean PSQI decreased from 7.1 to 5.4 among 22 patients whose active disease transitioned to remission ( p < 0.001). However, the score did not change in 11 patients with remission and developed disease flare (5.9–5.8). The mean PSQI was 7.7 and 6.3 in 4 and 53 patients whose disease remained active and inactive during follow-up, respectively. Multivariable longitudinal analysis revealed that PSQI was independently associated with active disease (odds ratio = 1.22) and inversely associated with IBDQ (β = −2.23). Sleep latency was evaluated by PSQI, and actigraphy was significantly correlated. Conclusions: Patients with IBD frequently experience poor sleep quality, which significantly correlates with active disease and worse quality of life longitudinally.
Background: CT‐P17 (Yuflyma), a biosimilar to adalimumab (Humira), offers a cost‐effective alternative with improved access for individuals with immune‐mediated inflammatory diseases (IMIDs). Assessing patient experience with autoinjector usability and comfort is crucial for ensuring adherence and satisfaction. This study is the first to evaluate patient‐reported satisfaction and safety of CT‐P17 specifically in people with Crohn's disease (CD).Aims: To evaluate patient satisfaction and safety of CT‐P17 in CD.Methods: This cross‐sectional study included 15 adults (median age 39.9 years) with CD from two Australian hospitals. All participants had prior experience with biologic therapy and used an autoinjector. Patients had either transitioned from adalimumab to CT‐P17 or had been receiving CT‐P17 for at least 4 weeks. Data collected included baseline demographics, the Harvey Bradshaw Index (HBI), and the Self‐Injection Assessment Questionnaire (SIAQ), a validated instrument assessing patient experience, confidence, and satisfaction with self‐injection. SIAQ domain scores ranged from 0 (worst) to 10 (best), with higher scores indicating more positive self‐injection experiences.Results: SIAQ scores indicated positive patient experiences. Mean (SD) scores showed high comfort (8.33 ± 1.67), strong self‐confidence (8.38 ± 1.53), positive self‐image (9.00 ± 2.64), minimal pain/skin reactions (9.22 ± 0.93), and ease of use (8.80 ± 1.89). Overall satisfaction was high (8.76 ± 1.38). HBI scores remained low (mean 0.7), indicating stable disease control.Conclusions: CT‐P17 is well‐tolerated in CD patients, with high satisfaction and minimal injection discomfort. Its ergonomic autoinjector design supports ease of use. While larger studies are needed, these findings support the broader adoption of adalimumab biosimilars to enhance patient autonomy and reduce healthcare costs.